The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.

The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.

The Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.

Device Description

The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).

Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.

A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.

Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.

The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.

The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.

The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.

Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.

Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.

The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.

The target concentration of the albumin is 4.3 g/dL.

AI/ML Overview

The provided document describes the Siemens Healthcare Diagnostics Trinidad CH System and its associated assays for Sodium (Na), Potassium (K), Chloride (Cl), and Albumin (Alb_P). The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices. It presents various performance characteristics of the device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail results. Instead, it presents performance data for various characteristics, and the underlying implication is that these results are acceptable for demonstrating substantial equivalence. The following table summarizes the reported performance characteristics:

Performance Characteristic	Analyte	Specimen Type	Acceptance Criteria (Implied)	Reported Device Performance (Trinidad CH System)
Detection Limit (LoB)	Na	Serum	Low value desirable	10.2 mmol/L
	K	Serum	Low value desirable	0.244 mmol/L
	Cl	Serum	Low value desirable	2.23 mmol/L
	Na	Urine	Low value desirable	4.72 mmol/L
	K	Urine	Low value desirable	0.00 mmol/L
	Cl	Urine	Low value desirable	4.86 mmol/L
	Albumin (Alb_P)	Serum	Low value desirable	0.1 g/dL
Detection Limit (LoD)	Na	Serum	Low value desirable	11.9 mmol/L
	K	Serum	Low value desirable	0.279 mmol/L
	Cl	Serum	Low value desirable	4.43 mmol/L
	Na	Urine	Low value desirable	5.30 mmol/L
	K	Urine	Low value desirable	0.079 mmol/L
	Cl	Urine	Low value desirable	5.47 mmol/L
	Albumin (Alb_P)	Serum	Low value desirable	0.2 g/dL
Quantitation Limit (LoQ)	Na	Serum/Plasma	Westgard model TE	40.4 mmol/L (4.8% TE)
	Na	Urine	Westgard model TE	5.35 mmol/L (1.78 mmol/L or 27% TE)
	K	Serum/Plasma	Westgard model TE	0.792 mmol/L (16.3% TE)
	K	Urine	Westgard model TE	1.03 mmol/L (22% TE)
	Cl	Serum/Plasma	Westgard model TE	38.3 mmol/L (10.3% TE)
	Cl	Urine	Westgard model TE	15.8 mmol/L (16% TE)
	Albumin (Alb_P)	Serum	Inter-assay precision < 10%	0.4 g/dL (< 10% inter-assay precision)
Linearity (Slope)	Na	Serum	Close to 1.0	0.98
	Na	Urine	Close to 1.0	0.94
	K	Serum	Close to 1.0	0.98
	K	Urine	Close to 1.0	1.00
	Cl	Serum	Close to 1.0	1.01
	Cl	Urine	Close to 1.0	1.04
	Albumin (Alb_P)	Serum	Close to 1.0	1.00
Precision (Within-Lab CV%)	Na	Serum (141)	Low CV% desirable	1.0%
	K	Serum (3.97)	Low CV% desirable	0.9%
	Cl	Serum (102)	Low CV% desirable	1.0%
	Albumin (Alb_P)	Serum (3.6)	Low CV% desirable	1.4%
Interferences (Bias)	Na, K, Cl, Alb_P	Serum/Urine	Bias < 10%	No interference detected at specified concentrations (unless noted as limitation)
Method Comparison (vs. Predicate) (Correlation Coefficient H)	Na	Serum	Close to 1.0	0.995
	K	Serum	Close to 1.0	0.998
	Cl	Serum	Close to 1.0	0.998
	Albumin (Alb_P)	Serum	Close to 1.0	0.996
Method Comparison (vs. Reference Method) (Slope)	Na	Serum/Plasma	Close to 1.0	0.97 (-2.33% Mean % Bias)
	K	Serum/Plasma	Close to 1.0	0.95 (-2.32% Mean % Bias)
	Cl	Serum/Plasma	Close to 1.0	1.04 (0.00% Mean % Bias)
Matrix Equivalency (Slope)	Na	Serum vs. Li Heparin	Close to 1.0	0.99
	K	Serum vs. Li Heparin	Close to 1.0	0.93
	Cl	Serum vs. Li Heparin	Close to 1.0	0.99
	Albumin (Alb_P)	Serum vs. Li Heparin	Close to 1.0	1.02
	Albumin (Alb_P)	Serum vs. EDTA Plasma	Close to 1.0	1.01

2. Sample sizes used for the test set and the data provenance

Detection Limit (LoB, LoD):

Na, K, Cl (Serum): 4 blank samples, 4 low/diluted patient serum samples. Each tested N=5, for 3 days, one run per day, 2 reagent lots (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte for LoB, similar for LoD).
Na, K, Cl (Urine): 4 blank samples, 4 low/diluted patient urine samples. Each tested N=5, for 3 days, one run per day, 2 reagent lots (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte for LoB, similar for LoD).
Albumin (Alb_P): 6 blank samples, 5 low/diluted serum samples. Blank samples: N=5 for 3 days, one run per day, 3 reagent lots (90 measurements per reagent lot). Low samples: N=5 for 3 days, one run per day, 3 reagent lots (75 measurements per reagent lot).

Limit of Quantitation (LoQ):

Na, K, Cl (Serum/Urine): 4 low samples of diluted serum/urine. Processed on 2 IMT sensor lots for 3 days, on one instrument (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte per matrix).
Albumin (Alb_P): 5 low samples of diluted serum pools. Processed on 3 reagent lots for 3 days, on one instrument (Total determinations: 5 x 5 x 3 x 3 = 225).

Linearity Study:

Na, K, Cl, Albumin: 9 equally spaced samples (prepared by mixing high and low concentration samples). Three replicates were measured for each sample. (Total determinations: 9 x 3 = 27 per analyte).

Precision Studies:

Na, K, Cl (Serum & Urine Pools/QCs), Albumin (Serum Pools/QCs): Tested n = 2 replicates, two times a day for at least 20 days. (Total replicates: 2 x 2 x 20 = 80 replicates for each sample type/level, and in some cases 84).

Interferences:

Na, K, Cl, Albumin: Samples spiked with interfering substances at varying concentrations (specific numbers of samples not explicitly stated, but it was a "worst case scenario" approach using low and high levels of measurand in serum pools).

Method Comparison (vs. Predicate Device):

Na: 106 serum samples, 101 urine samples.
K: 103 serum samples, 105 urine samples.
Cl: 108 serum samples, 102 urine samples.
Albumin: 130 serum samples.
Data Provenance: Remnant de-identified samples. Country of origin not specified, but the study was "conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel." This typically implies a US-based or corporate lab setting. The data is retrospective as it used "remnant de-identified samples" and "no patient history information was obtained."

Method Comparison (vs. Reference Method):

Na, K, Cl: 25 serum and plasma samples.
Data Provenance: The reference measurements were made at INSTAND e.V, Ubierstrasse 20, 40223 Düsseldorf, GERMANY. This implies European provenance for the reference method data, likely used against test samples generated by Siemens.

Matrix Equivalency:

Na, K, Cl: 50 matched serum and lithium heparin plasma samples.
Albumin: 59 matched sample sets (Serum vs. Lithium Heparin, Serum vs. EDTA plasma).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document describes performance studies for an in-vitro diagnostic device measuring analytes (Na, K, Cl, Albumin) directly. For such devices, "ground truth" is typically established by reference methods or predicate devices, rather than expert human interpretation of images or clinical findings.

For Method Comparison against a Predicate Device: The predicate device is the ADVIA 1800 Chemistry System (cleared under K990346), which itself is a legally marketed device and provides the comparative "truth." The document states that "laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting" conducted the tests.
For Method Comparison against Reference Methods: The reference methods used were flame emission spectrophotometry for Na and K, and coulometry for Cl. These are established analytical techniques. The measurements were made at INSTAND e.V, an organization involved in external quality assessment and reference materials, implying high-level analytical expertise. No "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for chemical measurements in this context.

4. Adjudication method for the test set

Not applicable. This is an in-vitro diagnostic device for quantitative chemical measurements. The "test set" refers to patient samples measured by the device itself or compared against a predicate/reference device, not assessments requiring clinical adjudication or consensus among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic device for automated chemical analysis, not an AI-assisted diagnostic imaging or clinical decision support tool for human readers. Therefore, an MRMC study and evaluation of human reader improvement with/without AI assistance are not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies described are standalone performance studies of the device (Trinidad CH System and its assays). The device performs automated, quantitative chemical analysis without continuous human intervention in the result generation. The results are compared against predicate devices or reference methods, which is a standalone comparison. Human involvement is limited to sample preparation, loading, and result review, which are standard for laboratory instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies was established through:

Comparison to a Legally Marketed Predicate Device: The ADVIA 1800 Chemistry System. This represents a "standard of care" or "established method" ground truth.
Comparison to Reference Methods: Flame emission spectrophotometry (for Na and K) and coulometry (for Cl). These are highly accurate and precise analytical techniques considered definitive for these analytes.
Spiked and Diluted Samples: For linearity, LoQ, and matrix equivalency studies, samples were artificially manipulated (spiked with analytes or diluted) to create samples with known or controlled concentrations.

8. The sample size for the training set

The document does not explicitly delineate a "training set" in the context of machine learning or AI. This is an automated clinical chemistry analyzer. The "training" of such a system typically refers to factory calibration and internal algorithm development based on extensive R&D data. The performance characteristics described are "test set" evaluations demonstrating the device's accuracy and precision in a real-world (or simulated real-world) setting after development. Therefore, a specific sample size for a machine learning training set is not provided or applicable in the way it would be for an AI/ML medical device.

9. How the ground truth for the training set was established

Not applicable as there is no explicitly defined "training set" in the machine learning sense. The device's underlying principles (photometric and ion selective electrode technology) are based on established chemical and physical laws. The process of making the instrument accurate and precise involves internal calibration and characterization using various standards and control materials with known values, rather than a "training set" with ground truth assigned by human experts for interpretive tasks.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA DUGGAN, REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE, M/S 514 PO BOX 6101 NEWARK DE 19714-6101

December 11, 2015

Re: K151767 Trade/Device Name: Trinidad CH System; TD-LYTE Integrated Multisensor (Na, K, Cl); TD-LYTE IMT Standard A; TD-LYTE IMT Standard B + Salt Bridge; Trinidad CH Albumin BCP Reagent (Alb P): Trinidad CH Albumin BCP Calibrator. Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ, CJW, JIX, JIT, JJE Dated: November 9, 2015 Received: November 10, 2015

Dear Laura Duggan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151767

Device Name

Trinidad CH System; TD-LYTE Integrated Multisensor (Na, K, Cl); TD-LYTE IMT Standard B + Salt Bridge; Trinidad CH Albumin BCP Reagent (Alb P); Trinidad CH Albumin BCP Calibrator

Indications for Use (Describe)

The TD-L YTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.

The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

ASSIGNED 510(K) NUMBER

The assigned 510(k) number is: K151767

APPLICANT AND DATE

Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: laura.j.duggan@siemens.com Phone: 302-631-7654 Fax: 302-631-6299

December 7, 2015

MANUFACTURER

Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235

PROPRIETARY NAME

Trinidad CH System TD-LYTE Integrated Multisensor (Na, K, CI) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator

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Photometric Chemistry Analyzer Sodium Test System Chloride Test System Potassium Test System Albumin Test System Calibrator

REGULATORY INFORMATION

Discrete photometric chemistry analyzer for clinical use (Class I)
Classification Name:	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation Section:	21CFR862.2160
Classification:	Class I
Product Code:	JJE
Panel:	Clinical Chemistry
Sodium, potassium, chloride and Albumin test systems and the associated calibrators (Class II)
Classification Name:	Electrode, Ion Specific, Sodium
Regulation Section:	21CFR862.1665, Sodium Test System
Classification:	Class II
Product Code:	JGS
Panel:	Clinical Chemistry
Classification Name:	Electrode, Ion Specific, Chloride
Regulation Section:	21CFR862.1170, Chloride Test System
Classification:	Class II
Product Code:	CGZ
Panel:	Clinical Chemistry
Classification Name:	Electrode, Ion Specific, Potassium
Regulation Section:	21CFR862.1600
Classification:	Class II
Product Code:	CEM
Panel:	Clinical Chemistry
Classification Name:	Calibrator, Multi-Analyte Mixture
Regulation Section:	21 CFR 862.1150
Classification:	Class II
Product Code:	JIX
Panel:	Clinical Chemistry
Classification Name:	Bromocresol Purple Dye-Binding, Albumin
Regulation Section:	21CFR862.1035, Albumin Test system
Classification:	Class II
Product Code:	CJW
Panel:	Clinical Chemistry
Classification Name:	Calibrator
Regulation Section:	21CFR862.1150, Calibrator
Classification:	Class II
Product Code:	JIT
Panel:	Clinical Chemistry

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PREDICATE DEVICE

The following table describes the predicate devices, device classifications, regulations and product codes associated with this pre-market notification:

New Product	Predicate Device	510(k) number	Device Class	Regulation	Product Code
Trinidad CH System	Siemens ADVIA® 1800 Chemistry*	K990346	I	862.2160	JJE
TD-LYTE Integrated Multisensor (Na, K, CI)	ADVIA® Sodium (Na)ADVIA® Potassium (K)ADVIA® Chloride (CI)	K990346	II	(Na)862.1665(K)862.1600(CI) 862.1170	JGSCEMCGZ
TD-LYTE IMT Standard A & TD-LYTE IMT Standard B + Salt Bridge	ADVIA® Chemistry ISE Serum StandardADVIA® Chemistry ISE Urine Standard	K990346	II	862.1150	JIX
Trinidad CH Albumin BCP Reagent (Alb_P)	ADVIA® Chemistry Albumin BCP Assay (ALBP)	K132664	II	862.1035	CJW
Trinidad CH Albumin BCP Calibrator	ADVIA® Chemistry Albumin BCP Calibrator	K132664	II	862.1150	JIT

*The ADVIA 1800 is a family member of the ADVIA 1650 cleared under K990346.

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TRINIDAD CLINICAL CHEMISTRY (CH) SYSTEM

TD-LYTE INTEGRATED MULTISENSOR (NA, K, CL)

Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.

TD-LYTE IMT STANDARD A & TD-LYTE IMT STANDARD B + SALT BRIDGE

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ALBUMIN BCP REAGENT

Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.

Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.

ALBUMIN BCP CALIBRATOR

The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.

The target concentration of the albumin is 4.3 g/dL.

INTENDED USE

The Intended uses for the system and representative assays are described below.

TRINIDAD CLINICAL CHEMISTRY (CH) SYSTEM

TD-LYTE INTEGRATED MULTISENSOR (NA, K, CL)

For in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride (Na, K, CI) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are

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used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

TD-LYTE IMT STANDARD A & TD-LYTE IMT STANDARD B + SALT BRIDGE

The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.

ALBUMIN BCP REAGENT

The Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

ALBUMIN BCP CALIBRATOR

The Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (ALB_P) on the Trinidad CH System.

INDICATION(S) FOR USE

See Intended Use above.

SUBSTANTIAL EQUIVALENCE INFORMATION

Both the Trinidad CH system and the predicate ADVIA 1800 Chemistry system employ prepackaged reagents in plastic, Siemens Healthcare Diagnostics reagent packs. Both systems automatically process and analyze clinical samples using a variety of in vitro diagnostic test assays. Both systems utilize indirect potentiometric technology for analysis of sodium, potassium and chloride electrolytes. A comparison of the important similarities and differences of these two automated analyzer systems is provided in the following table:

Technological and Features Comparison of Trinidad CH System vs. ADVIA 1800 Chemistry System

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Feature	Predicate Device:ADVIA 1800 ChemistrySystem	New Device:Trinidad CH System
Fundamental
Type of System	Random continuous access,batch, discrete processing	Same
Types of Measurements	Electrolyte, Photometricand Turbidimetric	Electrolyte, Photometric
Optical system	Oil bath and cuvette opticalpath length (10 mm)	Water bath and cuvetteoptical path length(7 mm)
Throughput Rate	1800 tests/hour, 1200tests/hour colorimetric, 600tests/hour ISE	Same
Assay Capacity On-board	56 slots including 3 ISE	Up to 70 slots including 3ISE
Sample Handling
Sample Containers	Tubes - 5 mL, 7 mL, 10 mLCups - 2 mL sample cups	Same
Sample Type	Whole blood, serum,plasma, CSF or urine	Same
Sample Tray	84 samples, positive sampleidentification	Samples identified anddelivered by Direct Load -60 positions
Bar Codes	Interleaved 2 of 5, code 39,code128, Codabar (NW7)	Same with addition ofreagent pack data matrix 2D
Dedicated STATPositions	84 positions/ Universal RackHandler available	All samples can be Statprocessed.(Not dedicated)
Universal Rack Handler(URH) Option	5-position rack handler, 425totalcapacity, continuous feed	Samples delivered byDirect load
Auto-repeat	Automatic repeat testingfrom the retained pre-dilutedsample or original sample	Automatic repeat testingfrom the retained pre-dilutedsample.
Auto-dilution	Automatic dilution fromretained pre-diluted sample	Same
Auto-reflex	Ability to perform 3 additionaltests based on results of firsttest	Not available.
Liquid Level Sensing	Capacitance technology	Same
Automatic Sample Pre-dilution	All samples diluted 1:5(differentdilutions possible)	Same
Original sample volume	2 to 30 µL; system uses anaverage of 2-3 µL per test	2 to 50 µL; system uses anaverage of 2-3 uL per test.
Sample probes	Primary probe picks upsample from primary tube orcup, dispenses todilution tray;secondary probedispenses saline into trayto dilute sample – onlyprimary probe has clotdetect, crash protect & liquidsurface verification	Dilution probe picks upprimary sample from primarytube or cup, and dispensesto dilution tray with saline todilute sample.A secondary probe(Sample Probe) transfers analiquot of diluted sample toreaction cuvette.All probes have liquidsurface verification.
Pre-diluted Sample	Retained until results areavailable	Same
Reaction Area
Reaction Tray	221 reusable plastic cuvettes	Same
Cuvette Optical Path Length	10 mm	7 mm
Reaction Volume	80-300 $µL$	80-240 $µL$
Reaction Bath	Inert fluorocarbon oilcirculation system, 37°C	Water bath, 37°C
Photometer	14 fixed wavelengths (12utilized)	11 fixed wavelengths
Turbidimetric Measurements	Made with photometer	Same
Light Source	12V, 50W halogen lamp,cooled by forced watercirculation	12 V, 50 W Halogen lamp /cooled by lamp coolantadditive and one LED
Assays	Endpoint, rate reaction, 2-point rate.	Endpoint, rate reaction, 2-point rate, sample blankcorrection
Reaction Times	3, 4, 5, 10, 15 and 21 minutes	3 to 10 minutes
Reagent Handling
Reagent Tray	2 refrigerated reagent trays,56 positions each; 4 of thesepositions may be occupiedby wash solutions and/ordiluents	2 refrigerated reagent trays;70 positions R170 Positions R2Up to 4 of the positions ofR2 may be occupied bywash solutions and/ordiluents.
Reagent cooling	6-14° C	4-12° C
Reagent Container	20, 40, 70 mL wedges	Approximate maximumwedge size of 50 mL. Packshave two wells with 1 or 2wells filled (depending onassay)
Reagent Capacity On- board	52 assay Reagents	Up to 70 Reagentsand 3 ISE
Dispensing System	2 probes with liquid levelsensing	Same
Reagent Dispense volume	10-100 µl per test	Same
Reagent InventoryManagement	Tracks tests remaining, lotnumber, on-board stabilityand expiration date	Same
Reagent Dilutions	Capability to diluteconcentrated reagents on-board	Same
Electrolyte Measurement
Method Principle	Ion Selective Electrode	Same
ISE Internal Standard	None	Internal Standard
Sample Volume	22 µL total for all three tests	25 µL for all three tests
Throughput Rate	600 tests/hour	Same
Calibration
Calibration Frequency	Up to 60 days	Up to 60 days
Auto-Calibration	User-defined time intervalor with new reagent cartridge	User-defined time interval orwith new reagent cartridge
Calibration/Control Tray	61 refrigerated positions forcalibrators, controls anddiluents	Calibrators and controlsdelivered by Direct Load /manual input.
General Specifications
Power Requirements	200/220/230 V +/-10%, 30A, 50/60 Hz, 3 KVA	200-240 VAC +/-10%, 8Amp, 50/60 Hz, 3.2 KVA
Water Requirements	Direct plumb - Deionizedwater Type I at the sourceType II at the system	Direct plumb - Lab GradeType 1 only
Water Consumption	30 liters per hour	33 liters per hour (maximum)
Dimensions	113.3 (h) x 148.0 (w) x 87.7(d) cm	Analytical Module:1363.5 (h) x 1452.5 (w) x1183.3 (d) mmDirect Load:1365 (h) x 425.3 (w) x 1150(d) mm
Weight	1,323 lbs. (540 kg)	CC Module:962 lbs. (437 kg)Direct Load331 lbs. (150 kg)
Electrical Compliance	UL, cUL, CE	Same
Computers/OS
CPU	Single Intel ProcessorrunningWindows XP Pro	Intel processor using Windows7
Display/Monitor	19" display (Touch screenis optional)	22" display with touch screen
Software
GUI Application	User interface unique toADVIA Chemistry systems	Universal InstrumentWorkstation, which will becommon to new Siemens IVDsystems
Result DatabaseCapacity	7 days of resultsmaintained in a flat filesystem	Stores up to 1MM results.
On-Line Help	Separate for Systemapplicationand ADVIA QC	Not available at this time
QC	ADVIA QC V3.2xapplicationprovides stored controlresults, Levy-Jenningsplotting, and statistics	Same
LIS Interfaces	LIS ASTM standards1394/1381,and J-ASTM, LIS HL7standards	Not available at this time
LAS Interfaces	Siemens URAP LASInterface	Utilize pick and place samplingrather than point in space
Real-Time Solutions(RTS) support	Interface to RTS viaLabCom protocol and RTSvia i2i protocol	Not available at this time
External printers	Parallel port and USBinterfaced printers	Not available at this time

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Below is a features comparison for the Trinidad CH system assays vs. their predicates:

Feature	Predicate Device:ADVIA 1800 ChemistrySystem	New Device:Trinidad CH System
Intended Use :Na, K, Cl	For in vitro diagnostic use inthe quantitative determinationof sodium in human serum,plasma (lithium heparin), andurine on the ADVIAChemistry systems.For in vitro diagnostic use inthe quantitative determinationof potassium in humanserum, plasma (lithiumheparin), and urine on theADVIA Chemistry systems.	For in vitro diagnostic usein the quantitativedetermination of sodium,potassium and chloride(Na, K, Cl)in human serum, plasmaand urine using theTrinidad CH System.
	For in vitro diagnostic use inthe quantitative determinationof chloride in human serum,plasma, and urine on theADVIA Chemistry systems.
Albumin BCP	For in vitro diagnostic use inthe quantitative measurementof albumin in human serumor plasma on ADVIA®Chemistry systems.	For in vitro diagnostic usein the quantitativemeasurement of albuminin human serum orplasma on Trinidad CHSystem.
Indications for Use:Na, K, Cl	Sodium measurements areused in the diagnosis andtreatment of gross changes inwater and salt balance,aldosteronism, diabetesinsipidus, adrenalhypertension, Addison'sdisease, dehydration,inappropriate antidiuretichormone secretion, diabeticacidosis, severe diarrhea, orother diseases involvingelectrolyte imbalance.Potassium measurementsare used to monitorelectrolyte balance in thediagnosis and treatment ofprimary aldosteronism,metabolic alkalosis, diarrhea,severe vomiting, diureticadministration, diabeticketoacidosis, and otherdiseases.Chloride measurements areused for their inferential valueand are helpful in diagnosingdisorders of acid-base andwater balance. It is especially	Measurements of sodiumobtained bythis device are used in thediagnosis and treatmentof aldosteronism(excessive secretion ofthe hormonealdosterone), diabetesinsipidus (chronicexcretion of largeamounts of dilute urine,accompanied byextreme thirst), adrenalhypertension, Addison'sdisease (caused bydestruction of the adrenalglands),dehydration, inappropriateantidiuretic hormonesecretion, or otherdiseases involvingelectrolyteimbalance.Measurements ofpotassium obtained bythis device are used tomonitor electrolytebalance inthe diagnosis andtreatment of diseaseconditions characterized
	chloride during the correctionof hypokalemic alkalosis andalso during severe, prolongedvomiting, which can lower theserum chloride level.	by low or high bloodpotassium levels.Chloride measurementsare used in the diagnosisand treatment ofelectrolyte and metabolicdisorderssuch as cystic fibrosis anddiabetic acidosis.
Albumin BCP	Albumin measurements areused in the diagnosis andtreatment of numerousdiseases primarily involvingthe liver or kidneys.	Albumin measurementsare used in the diagnosis andtreatment ofnumerous diseasesprimarily involving theliver or kidneys.
Device Technology:Na, K, CI	Indirect potentiometricmeasurements with ionselective electrodes	Indirect potentiometricmeasurements withIntegrated MultisensorTechnology (IMT)
Albumin BCP	bromocresol purple (BCP)dye-binding method	Same
Sample Type:Na, K, CI	Serum/plasma/urine	Same
Albumin BCP	Serum/plasma	Same
Analytical MeasuringInterval:Na, K, CI	Serum/PlasmaNa: 100 - 200 mmol/LK: 1.0 - 10.0 mmol/LCl: 15 - 200 mmol/LUrineNa: 10 - 400 mmol/LK: 3.0 – 300 mmol/LCl: 15 - 400 mmol/L	Serum/PlasmaNa: 50.0 to 200 mmol/LK: 1.0 to 10.0 mmol/LCl: 50.0 to 200 mmol/LUrineNa: 10 to 300 mmol/LK: 2 to 300 mmol/LCl: 20 to 330 mmol/L
Albumin BCP	ALBP 0.6-8.0 g/dL	Alb_P 0.5-8.0 g/dL

Reference Interval:Na, K, Cl	Serum/PlasmaNa: 132 – 146 mmol/LK (Serum): 3.5 – 5.5 mmol/LK (Plasma/males): 3.5 – 4.5mmol/LK (Plasma/females): 3.4 – 4.4mmol/LCl: 99 – 109 mmol/L	Serum/PlasmaNa: 136–145 mmol/LK (serum): 3.5–5.1mmol/LK (plasma): 3.4-4.5mmol/LCl: 98–107 mmol/L
	UrineNa: 40 – 220 mmol/dayK: 25 – 125 mmol/dayCl: 110 - 250 mmol/day	UrineSame
Albumin BCP	ALBP: 3.4-5.0 g/dL	Alb_P Same
Interferences:Na, K, Cl	Na: Bilirubin (Conjugated) –25 mg/dLBilirubin (Unconjugated) – 25mg/dLLipemia – 500 mg/dLHemoglobin - 500 mg/dL	Na: Bilirubin(Conjugated) – 60 mg/dLBilirubin (Unconjugated) –60 mg/dLLipemia (Intralipid®) –3000 mg/dLHemoglobin - 750 mg/dL
	K:Bilirubin (Conjugated) – 25mg/dLBilirubin (Unconjugated) – 25mg/dLLipemia - 500 mg/dL	K: Bilirubin (Conjugated) –60 mg/dLBilirubin (Unconjugated) –60 mg/dLLipemia (Intralipid®) –3000 mg/dL
	Cl:Bilirubin (Conjugated) – 25mg/dLBilirubin (Unconjugated) – 25mg/dLLipemia – 500 mg/dLHemoglobin - 500 mg/dL	Cl: Bilirubin (Conjugated)– 60 mg/dLBilirubin (Unconjugated) –60 mg/dLLipemia (Intralipid®) –3000 mg/dLHemoglobin - 750 mg/dL
Albumin BCP	ALBP: Bilirubin (Conjugated)– 60 mg/dL	Alb_P Bilirubin(Conjugated) – 30 mg/dL
	Bilirubin (Unconjugated) - 60 mg/dL	Bilirubin (Unconjugated) - 30 mg/dL
	Lipemia - 500 mg/dLHemoglobin - 500 mg/dL	Lipemia – 500 mg/dLHemoglobin – 600 mg/dL
Standardization:
Na, K, CI	NA: Flame photometricmethod with NIST referencestandardsK: Flame photometric methodwith NIST reference serumCl: Coulometric method withNIST standards	Same
Albumin BCP	ALBP: ERM-DA470kReference Material	Same
Calibration Frequency:
Na, K, CI	Daily	Every 4 hours
Albumin BCP	Every 60 days	Every 30 days
Calibrators:
Na, K, CI	ADVIA Chemistry ISE SerumStandard & ADVIA ChemistryISE Urine Standard Set	TD-LYTE IMT Standard Aand TD-LYTE IMTStandard B + Salt Bridge
Albumin BCP	ADVIA Chemistry AlbuminBCP Calibrator	Albumin BCP Calibrator
Calibrator Matrix:
Na, K, CI	Na/K/CI: Buffered Aqueousmatrix	Same
Albumin BCP	ALBP: Human Serum	Same
Calibrator Form:Na, K, CI	Na/K/CI: liquid	Same
Albumin BCP	ALBP: Lyophilized	Same
Number of CalibratorLevels:
Na, K, CI	Na/K/CI: Two for serumand Two for Urine	Two for serum/urine
Albumin BCP	ALBP: One	Same

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ASSAY PERFORMANCE CHARACTERISTICS

Assay performance comparison results for the representative Trinidad CH system assays and their predicate assays were obtained by processing the appropriate body fluids. Summary statistics for each representative assay are provided. These data demonstrate substantial equivalency of the representative assays processed on the Trinidad CH system versus their predicate assays. The following data represent typical assay performance.

DETECTION LIMIT

The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline.

TD-LYTE Integrated Multisensor (Na, K, Cl)Limit of Detection Results with Serum
Limit	Protocol	Result
LoB	4 samples with no analytewere tested (N=5) for 3days, one run per day, 2reagent lots,	Na: 10.2 mmol/LK: 0.244 mmol/LCl: 2.23 mmol/L
LoD	4 low or diluted patientserum samples weretested (N=5) for 3 days,one run per day, 2 reagentlots	Na: 11.9 mmol/LK: 0.279 mmol/LCl: 4.43 mmol/L
TD-LYTE Integrated Multisensor (Na, K, Cl)Trinidad CH Limit of Detection Results with Urine
Limit	Protocol	Result

SODIUM, POTASSIUM, CHLORIDE

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LoB	4 samples with no analytewere tested (N=5) for 3days, one run per day, 2reagent lots,	Na: 4.72 mmol/LK: 0.00 mmol/LCl: 4.86 mmol/L
LoD	4 low or diluted patienturine samples were tested(N=5) for 3 days, one runper day, 2 reagent lots	Na: 5.30 mmol/LK: 0.079 mmol/LCl: 5.47 mmol/L

The nonparametric approach described in EP-17A2 was followed to determine the Limit of Detection.

ALBUMIN

LoB and LoD were determined as described in CLSI Document EP17-A2. Six blank samples composed saline diluent and water were processed with three reagent lots for three days, on one instrument for a total of 90 measurements per reagent lot. Five low samples composed of diluted serum were processed on three reagent lots for three days, on one instrument for a total of 75 measurements per lot. LoB: used nonparametric approach. LoB = 95th percentile of all values LoB studies were completed with 3 reagent lots.

Trinidad CH Albumin_PLimit of Detection Results
Limit	Protocol	Result
LoB	6 samples with no analytewere tested (N=5) for 3 days,one run per day, 3 reagent lots	0.1 g/dL
LoD	5 low and diluted patientserum samples were tested(N=5) for 3 days, one run perday, 3 reagent lots	0.2 g/dL

SODIUM, POTASSIUM, CHLORIDE_LOQ

The Limit of Quantitation (LoQ) for serum and urine fluids were determined as described in CLSI Document EP17-A2 for Na, K and Cl. Total Error is calculated using: TE = bias + 2 * SD. The reference values are traceable to the reference standard. For both serum and urine, four low samples composed of diluted samples (serum or urine), were processed on two IMT sensor lots for three days, on one instrument for a total of 60

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measurements per lot. The average, SD, and bias relative to the reference values were calculated for each sample per reagent lot. These values were used to calculate the TE per the Westgard model for each sample.

The LoQ for Na for serum and plasma is 40.4 mmol/L [40.4 mEq/L]. based on 120 determinations: and observed total error of 4.8% calculated using the Westgard model. The LoQ for Na for urine is 5.35 mmol/L [5.35 mEq/L], based on 120 determinations; and observed total error of 1.78 mmol/L [1.78 mEq/L] or 27% calculated using the Westgard model.

The LoQ for K for serum and plasma is 0.792 mmol/L [0.792 mEq/L], based on 120 determinations; and observed total error of 16.3% calculated using the Westgard model. The LoQ for K for urine is 1.03 mmol/L [1.03 mEg/L], based on 120 determinations; and observed total error of 22% calculated using the Westgard model.

The LoQ for Cl for serum and plasma is 38.3 mmol/L [38.3 mEq/L], based on 120 determinations; and observed total error of 10.3% calculated using the Westgard model. The LoQ for Cl for urine is 15.8 mmol/L [15.8 mEq/L], based on 120 determinations; and observed total error of 16% calculated using the Westgard model.

ALBUMIN LOQ

Five low samples composed of diluted serum pools were processed on three reagent lots for three days, on one instrument for a total of 75 measurements per reagent lot. The lowest sample concentration that met the LoQ inter-assay precision acceptance criteria is 0.41 g/dL. Limit of Quantitation (LoQ) is 0.4 g/dL (4 g/L) based on 225 determinations, with an inter-assay precision of < 10%.

LINEARITY STUDY

Linearity was evaluated for serum and urine samples by using 9 equally spaced samples which spanned the assays' measuring interval. Each was prepared by mixing high and low concentration samples across the measurement interval as described in CLSI Evaluation of the Linearity of Quantitative Measurement Procedure (EP06-A). Native serum and urine pools were spiked with NaCI or KCI to prepare the high samples and diluted with water to prepare low samples. Three replicates were measured for each sample. The mean of these replicates was used for the calculations.

Regression Statistics

Sodium

Range of samples	Slope	Intercept	N
serum47.4 –208 mmol/L	0.98	0.19	9

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urine
7.87 – 337 mmol/L	0.94	0.35	9

Potassium

Range of samples	Slope	Intercept	N
serum0.980 – 10.0 mmol/L	0.98	0.00	9
urine0.238 – 314 mmol/L	1.00	-0.379	9

Chloride

Range of samples	Slope	Intercept	N
serum45.9 – 205 mmol/L	1.01	-0.22	9
urine10.3 – 397 mmol/L	1.04	-0.35	9

Albumin

Range of samples	Slope	Intercept	N
serum0.2 – 9.18 g/dL	1.00	0.056	9

PRECISION STUDIES

Precision testing was performed in accordance with CLSI EP05-A2 Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline -Second Edition. Precision was tested n = 2 replicates, two times a day for at least 20 days for a total of at least 80 replicates with controls, serum pools and urine pools for the Na, K, CI and Alb_P assays on one instrument. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP05-A2. The data are summarized in the following tables:

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Specimen	N	Mean (mmol/L)	Repeatability		Within-Lab
			SD (mmol/L)	CV (%)	SD (mmol/L)	CV (%)
Serum Pool	80	71.6	0.36	0.5	0.60	0.8
Serum QC	80	114	0.69	0.6	1.19	1.0
Serum QC	80	141	0.84	0.6	1.41	1.0
Serum QC	80	154	0.82	0.5	1.36	0.9
Urine Pool	80	32.2	0.33	1.0	0.50	1.5
Urine QC	80	80.3	0.52	0.6	0.83	1.0
Urine QC	80	177	1.23	0.7	1.85	1.0
Urine Pool	80	284	1.7	0.6	3.17	1.1

SODIUM (NA)

SD = standard deviation

CV = coefficient of variation

POTASSIUM (K)

			Repeatability		Within-Lab
Specimen	N	Mean (mmol/L)	SD (mmol/L)	CV (%)	SD (mmol/L)	CV (%)
Serum QC	80	2.70	0.01	0.4	0.03	1.0
Serum QC	80	3.97	0.02	0.5	0.03	0.9
Serum Pool	80	5.88	0.03	0.4	0.04	0.7
Serum QC	80	7.31	0.04	0.5	0.06	0.8
Urine QC	80	31.2	0.15	0.5	0.30	0.9
Urine QC	80	73.7	0.39	0.5	0.69	0.9
Urine Pool	80	258	2.01	0.8	2.95	1.1

SD = standard deviation

CV = coefficient of variation

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			Repeatability		Within-Lab
Specimen	N	Mean (mmol/L)	SD(mmol/L)	CV(%)	SD(mmol/L)	CV(%)
Serum QC	80	78.1	0.73	0.9	1.15	1.5
Serum QC	80	102	0.83	0.8	1.05	1.0
Serum QC	80	114	0.78	0.7	0.99	0.9
Serum Pool	80	189	1.01	0.5	1.30	0.7
Urine Pool	80	42.7	0.26	0.6	0.71	1.7
Urine QC	80	99.7	0.65	0.6	0.97	1.0
Urine QC	80	194	0.99	0.5	1.76	0.9
Urine Pool	80	280	1.23	0.4	2.16	0.8

SD = standard deviation

CV = coefficient of variation

ALBUMIN (ALB_P)

			Repeatability		Within-Lab
Specimen	N	Mean(g/dL)	SD(g/dL)	CV(%)	SD(g/dL)	CV(%)
Serum QC	84	2.7	0.03	1.2	0.03	1.2
Serum QC	80	3.6	0.04	1.1	0.05	1.4
Serum QC	84	7.1	0.05	0.7	0.07	1.0
Serum Pool	80	3.3	0.04	1.4	0.06	1.8

SD = standard deviation

CV = coefficient of variation

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INTERFERENCES

CLSI EP7A2 was followed for the interference testing. The interference study was conducted using a "paired difference worst case scenario" approach where these compounds were spiked into fresh sample pools containing either low or high levels of measurand in serum pools.

Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference. Dilution studies were conducted to determine the level at which the spiked substance no longer displayed significant interference. Dilution studies were conducted at two analyte concentrations, if both sample pools show significant interference. This study was conducted as needed for both serum pools.

Approximate Concentration (within 10%) of Analytes in Test Pools
Analyte	Matrix	Low	High
Na	serum	130 mmol/L	150 mmol/L
K	serum	3 mmol/L	5 mmol/L
Cl	serum	90 mmol/L	110 mmol/L
Alb_P	Serum	3.5 g/dL	5.0 g/dL

Approximate Concentration (within 20%) of Analytes in Test Pools
Analyte	Matrix	Low	High
Na	urine	50 mmol/L	200 mmol/L
K	urine	25 mmol/L	200 mmol/L
Cl	urine	50 mmol/L	200 mmol/L

No interference was detected at the following analyte concentrations.

SODIUM

Interferent	Tested Concentration
Hemoglobin	750 mg/dL (0.47 mmol/L)
Conjugated Bilirubin	60 mg/dL (1026 $μ$ mol/L)
Unconjugated Bilirubin	60 mg/dL (1026 $μ$ mol/L)
Lipemia (Intralipid)	3000 mg/dL (33.9 mmol/L)
Potassium	10 mM
Magnesium	20 mg/dL
Calcium	20 mg/dL
Lithium	3.5 mg/dL
Borate	2.5 mg/dL

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Acetate	20 mg/dL
Benzoate	10 mg/dL
Citrate	1 g/dL
Ammonium	0.5 mmol/L
Thiopental	14 mg/dL

|--|

Interferent	Tested Concentration
Hemoglobin	500 mg/dL
Conjugated Bilirubin	60 mg/dL
Unconjugated Bilirubin	60 mg/dL
Lipemia (Intralipid)	2000 mg/dL
Acetaminophen	200 mg/dL
N-Acetyl cysteine	2 mg/dL
Ascorbic Acid	60 mg/dL
Sodium Cefoxitin	660 mg/dL
Gentamycin Sulfate	10 mg/dL
Ibuprofen	500 mg/dL
Levodopa	100 mg/dL
Ofloxacin	90 mg/dL
Phenazopyridine	30 mg/dL
Tetracycline	15 mg/dL
Low pH	pH 4
High pH	pH 8

POTASSIUM

Serum/Plasma
Interferent	Tested Concentration
Conjugated Bilirubin	60 mg/dL (1026 µmol/L)
Unconjugated Bilirubin	60 mg/dL (1026 µmol/L)
Lipemia (Intralipid)	3000 mg/dL (33.9 mmol/L)
Magnesium	20 mg/dL
Calcium	20 mg/dL
Lithium	3.5 mg/dL
Borate	2.5 mg/dL
Acetate	20 mg/dL
Benzoate	10 mg/dL

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Citrate	1 g/dL
Ammonium	0.5 mmol/L
Iron	250 mg/dL

Urine

Interferent	Tested Concentration
Hemoglobin	500 mg/dL
Conjugated Bilirubin	60 mg/dL
Unconjugated Bilirubin	60 mg/dL
Lipemia (Intralipid)	2000 mg/dL
Acetaminophen	200 mg/dL
N-Acetyl cysteine	2 mg/dL
Ascorbic Acid	60 mg/dL
Sodium Cefoxitin	660 mg/dL
Gentamycin Sulfate	10 mg/dL
Ibuprofen	500 mg/dL
Levodopa	100 mg/dL
Ofloxacin	90 mg/dL
Phenazopyridine	30 mg/dL
Tetracycline	15 mg/dL
Low pH	pH 4
High pH	pH 8

CHLORIDE

Serum/Plasma

Serum/Plasma
Interferent	Tested Concentration
Hemoglobin	750 mg/dL (0.47 mmol/L)
Conjugated Bilirubin	60 mg/dL (1026 µmol/L)
Unconjugated Bilirubin	60 mg/dL (1026 µmol/L)
Lipemia (Intralipid)	3000 mg/dL (33.9 mmol/L)
Borate	2.5 mg/dL
Acetate	20 mg/dL
Benzoate	150 mg/dL
Citrate	0.5 g/dL
Sulfate	2 mmol/L
Salicylate	50 mg/dL
Oxalate	0.5 mmol/L
Fluoride	250 mg/dL

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lodine	25 mg/dL
Bromide	50 mg/dL

Urine

Interferent	Tested Concentration
Hemoglobin	500 mg/dL
Conjugated Bilirubin	60 mg/dL
Unconjugated Bilirubin	60 mg/dL
Lipemia (Intralipid)	2000 mg/dL
Acetaminophen	200 mg/dL
N-Acetyl cysteine	2 mg/dL
Ascorbic Acid	60 mg/dL
Sodium Cefoxitin	660 mg/dL
Gentamycin Sulfate	10 mg/dL
Ibuprofen	400 mg/dL
Levodopa	100 mg/dL
Ofloxacin	80 mg/dL
Phenazopyridine	30 mg/dL
Tetracycline	15 mg/dL
Low pH	pH 4
High pH	pH 8

Limitations

Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium. Intracellular potassium concentration is 30-50 fold greater than that of extracellular serum or plasma.

Samples exposed to Benzalkonium salts present in certain blood catheter devices will cause falsely elevated sodium and potassium measurements.**

Citrate at 1 g/dL decreases the chloride result in serum/plasma at 82.4 mmol/L by -11.9%. Fluoride at 1 g/dL increases the chloride result in serum/plasma at 81.7 mmol/L by 40.0% and 101 mmol/L by 55.4%. lodine at 50 mg/dL increases the chloride result in serum/plasma at 82.2 mmol/L by 15.7%. Bromide at 200 mg/dL increases the chloride result in serum/plasma at 82.1 mmol/L by 54.7% and 101 mmol/L by 36.4%. Iron at 1 g/dL increases the potassium result in serum/plasma at 2.75 mmol/L by 16.4% and 4.54 mmol/L by 11.1%.

lbuprofen at 500 mg/dL biases Chloride results in urine at 47.2 mmol/L by 18.5%. Ofloxacin at 90 mg/dL biases Chloride results in urine at 55.8 mmol/L by -11.3%.

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** Koch TR, Cook JD. Benzalkonium interference with test methods for potassium and sodium. Clin Chem. 1990;36:807-8.

		ALBUMIN (ALB			P)

Interferent Concentration	Assay
Hemoglobin 600 mg/dL [0.37 mmol/L]	ALB_P
Conjugated Bilirubin 30 mg/dL [513 µmol/L]	ALB_P
Unconjugated Bilirubin 30 mg/dL [513 µmol/L]	ALB_P
Lipemia (Intralipid) 500 mg/dL [5.65 mmol/L]	ALB_P

DILUTION RECOVERY OF SAMPLES

SODIUM. POTASSIUM. CHLORIDE

Siemens validated a manual rerun condition that extends the reportable range up to 600 mmol/L [600 mEq/L] for Na urine, 600 mmol/L [600 mEq/L] for K urine, and 660 mmol/L [660 mEq/L] for Cl urine. Manually dilute 1 part urine with 1 part reagent grade water. Enter dilution factor of 2. Reassay. Resulting readout is corrected for dilutions.

METHOD COMPARISON

SODIUM, POTASSIUM, CHLORIDE

The predicate device selected for the method comparison study was the ADVIA 1800 Chemistry System which is a member of the ADVIA 1650 Chemistry System cleared under K990346. Remnant de-identified samples were tested. No patient history information was obtained on these samples. Inclusion data criteria are not applicable. The study included native, spiked, and diluted samples to properly span the assay ranges.

These studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel. The personnel conducting the study were laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting. They were trained on the operation of both the device and the predicate device. A split sample method comparison, following EP09-A3, demonstrated good agreement between the Trinidad CH System and the predicate ADVIA 1800 Chemistry with patient samples.

The results across the full assay ranges for Sodium, Potassium and Chloride were analyzed by Passing-Bablok regression. One replicate of each sample was tested and used in the analysis.

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ComparativeAssay	SpecimenType	Slope	Intercept(mmol/L)	Sample Range on theADVIA(mmol/L)	CorrelationCoefficient (r)	N
ADVIA 1800ChemistrySystem Sodium(Na)	Serum	1.00	-4.00	101-197.1	0.995	106
ADVIA 1800ChemistrySystem Sodium(Na)	Urine	1.01	0.97	12-283	1.000	101
ADVIA 1800ChemistrySystemPotassium (K)	Serum	0.96	0.10	1.50-9.90	0.998	103
ADVIA 1800ChemistrySystemPotassium (K)	Urine	1.03	-0.67	3.7 - 280.9	0.998	105
ADVIA 1800ChemistrySystem Chloride(Cl)	Serum	1.00	0.00	59-191	0.998	108
ADVIA 1800ChemistrySystem Chloride(Cl)	Urine	0.99	-0.28	19 - 321	0.999	102

ALBUMIN

The albumin method comparison statistics were calculated with standard linear regression.

ComparisonAssay (x)	SpecimenType	Slope	Intercept(g/dL)	SampleRange(g/dL)	CorrelationCoefficient(r)	N
ADVIA Chemistry1800 ALBP	Serum	0.99	0.01	0.9 -7.9	0.996	130

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METHOD COMPARISON TO REFERENCE METHOD

SODIUM, POTASSIUM, CHLORIDE

A second method comparison was completed with 25 serum and plasma samples on the Trinidad CH and the Reference Methods for sodium, potassium and chloride. Samples were tested n=1. The reference measurement procedures used were flame emission spectrophotometry for Na and K, and coulometry for Cl. Reference measurements were made at INSTAND e.V, Ubierstrasse 20, 40223 Düsseldorf, GERMANY. Some samples were either diluted with water or spiked with NaCI or KCI to properly span the assay ranges.

Linear regression model = Least-squares. N=1 replicate per sample IMT reagent Lot #: 5AD102

Assay	Slope	Y-int (mmol/L)	N	Mean % Bias	Range
Na	0.97	0.59	25	-2.33%	73.1 to 183.2 mmol/L(mEq/L)
K	0.95	0.13	25	-2.32%	2.22 to 8.97 mmol/L(mEq/L)
Cl	1.04	-4.66	25	0.00%	55 to 148 mmol/L(mEq/L)

MATRIX EQUIVALENCY

SODIUM, POTASSIUM, CHLORIDE

Serum and lithium heparin plasma equivalency was demonstrated for the Sodium, Potassium and Chloride assays on the Trinidad CH Instrument System by testing fifty matched samples. Some samples were diluted with water or spiked with NaCI or KCI to obtain samples spanning the assay measuring intervals. The table below summarizes the Deming linear regression statistics.

Assay	N	Range of Samples	Slope	Y-Intercept (mmol/L)
Na	50	92.6196	0.99	0.51
K	50	1.479.79	0.93	0.02
Cl	50	64.4163	0.99	0.52

Linear regression model = Deming

N=1 replicate per sample

(1 mmol/L = 1 mEq/L)

ALBUMIN

Lithium heparin plasma and EDTA plasma sample types were demonstrated to yield equivalent to those from serum samples on the Trinidad CH Instrument System for the Albumin. Fifty-nine matched sample sets were tested.

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Comparison	N	Range of Samples		Slope	Y-Intercept (g/dL)
Serum vs. LithiumHeparin	59	0.5	6.4	1.02	-0.01
Serum vs. EDTAplasma	59	0.5	6.4	1.01	-0.01

Linear regression model = Deming

N=1 replicate per sample

EXPECTED VALUES

SODIUM, POTASSIUM, CHLORIDE

The expected values for adult based serum, plasma and 24-hour urine output are cited from the literature":

Serum (Adults)

Sodium: 136-145 mmol/L Potassium: 3.5-5.1 mmol/L Chloride: 98-107 mmol/L

Plasma (Adults)

Sodium: 136-145 mmol/L Potassium: 3.4-4.5 mmol/L Chloride: 98-107 mmol/L

Urine, 24 hour (Adults)

Sodium: 40-220 mmol/24h Potassium: 25-125 mmol/24h Chloride: 110-250 mmol/24h

1 Tietz Fundamentals of Clinical Chemistry, Fifth Edition, Edited by Carl A. Burlis and Edward R. Ashwood, W.B. Saunders Company, 2001:970, 1004,1009 (ISBN 0-7216-8634-6).

ALBUMIN

The reference range for albumin is 3.4 – 5.0 g/dL for adults2. This range was verified through testing of 20 adults without renal disease, liver disease, thyroid disease, diabetes, pregnancy or hypertension medication, per CLSI EP28-A3c.

2Willey DA, Savory J, Lasky F. An Evaluation of a Revised Albumin Method for the aca® discrete clinical analyzer, Du Pont Company, Wilmington, DE, August 1982.

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The automated Trinidad CH system and ADVIA 1800 Chemistry systems are substantially equivalent in principle and performance based on the similarity of system design and function. In addition, the performance and results of the representative test assays (sodium, potassium, chloride and albumin) are equivalent to their respective predicates as demonstrated through method comparison and other performance attributes.

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.